Effect of Chemotherapy on TMB in NSCLC

NCT03683407 | Unknown

• 1 other identifier: COTMB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Tumor mutation burden is identified as an important biomarkers for predicting PD-1/PD-L1 inhibitors in advanced Non-Small Cell Lung Cancer. Several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of PD-1/L1 immunotherapy in NSCLC such as Checkmate-227, Impower-150, Keynote-189, etc. Pre-clincial experiment shows that chemotherapy could increase CD8 TIL infiltration in tumor microenvironment, activate T cell immune reaction. However, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced NSCLC patients. The present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced NSCLC patients.

Conditions

Chemotherapy Effect; Immunotherapy; Tumor Mutation Burden; PD-1/L1 Inhibitor

Outcome Measures

Primary Outcomes (1)

• Tumor Mutation Burden Change

  Tumor mutation burden will be calculated using a 520 genes NGS panel

  every 6 weeks up to progression disease

Study Arms (1)

Chemotherapy Group

All participants are advanced NSCLC without druggable gene mutation (EGFR, ALK, ROS-1, Met, Ret. BRAF, etc), who would receive platinum-based chemotherapy.

Other: Next-Genernation Sequence

Interventions

Next-Genernation Sequence OTHER

Tumor Mutation burden will be evaluated using NGS after 2-cycle chemotherapy, 4-cycle chemotherapy, or at progressive disease

Chemotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced NSCLC without druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)

You may qualify if:

• Advanced NSCLC diagnosed histologically; Expected survival ≥ 6 month;
• Without Druggable molecular events (EGFR, ALK, c-Met, BRAF, Ret, etc)
• ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

You may not qualify if:

• Patient can not comply with research program requirements or follow-up;
• Patient will receive immunotherapy;

Sponsors & Collaborators

• Baodong Qin: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA from tumor tissue or circulating Tumor DNA

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 25, 2018
• Study Start: September 1, 2018
• Primary Completion: February 28, 2019
• Study Completion: August 31, 2019
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)